The Protocol Review and Monitoring System (PRMS) was implemented in 1990 to oversee research involving cancer patients in the facilities of the institutions that define KCI. The main objectives of the PRMS include the following: 1) review the scientific merit of cancer research protocols; 2) ensure prioritization of therapeutic cancer protocols according to KCI's scientific priorities; and 3) monitor scientific progress. The Protocol Review and Monitoring Committee is composed of a complementary mix of senior and junior investigators from various disciplines, and specialties, as well as representatives from the Biostatistics Core, nursing and physician extenders, and administrative support staff from the Clinical Trials Office Core. The members of the committee represent a sufficient size, and breadth of expertise to conduct a critical, fair scientific review of all clinical research protocols involving cancer patients in the institutions comprising the Cancer Center. The PRMS provides internal oversight of the scientific and research aspects of the cancer trials, in addition to assuring that its clinical resources are engaged to ensure the best practices for scientific endeavors and applications. The function of the PRMS is complementary to that ofthe WSU Human Investigations Committee (HIC), which focuses on the protection of human subjects. The PRMS is not intended to duplicate or overlap the responsibilities of the WSU HIC, nor is it intended to perform an auditing or data and safety monitoring function. The PRMS evaluates all cancer clinical trials, whether derived and supported from institutional resources or from industry. However, the PRMS does not duplicate the results of traditional peer review, which includes protocols supported by various NIH mechanisms (e.g., ROIs, UOIs, POIs, UIOs and P50s), and clinical research protocols approved by the NCI's Cancer Therapy Evaluation Program. Scientific review takes into account the specific rationale, study design, duplication of studies already in progress elsewhere and at the Cancer Center, adequacy of biostatistical input, and feasibility for completion of the study within a reasonable time frame.